Translation of an Evidence-based Exercise Program for Remote Delivery to Rural, Older Cancer Survivors
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Vermont
- Enrollment
- 39
- Locations
- 1
- Primary Endpoint
- Fatigue
Study Overview
Brief Summary
The proposed pilot study will test the acceptability and feasibility of a sixteen-week, two-arm randomized control physical activity intervention in older cancer survivors. The Survivors Taking Action with Remote exercise Training (JumpSTART) program is intended for cancer survivors (Stage I-III) age 60 or older, living in rural areas. The goal of this intervention is to increase physical activity opportunities for cancer survivors who are geographically isolated by offering exercise classes (EnhanceFitness) online. The real-time instruction of group-based classes helps older adults to exercise by establishing relationships, fostering social support and receiving corrective and supportive feedback from instructors that enhance self-efficacy for exercise.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Rural residence by self-report and confirmed with Rural-Urban Commuting Area Codes
- •Stage I-III cancer history
- •Completion of adjuvant chemotherapy, radiation therapy, or surgery for cancer diagnosis
- •Age 60 years or older
- •Ability to walk for exercise
- •Self-reported minimal or inconsistent participation in strengthening exercise and physical activity (< 150 minutes/week moderate-to-vigorous physical activity; confirmed with baseline accelerometer measures)
- •Clearance for exercise based on a modified, combined Screening Cancer Survivors for Unsupervised Moderate-to-Vigorous Intensity Exercise and the Screening for Physical Activity Readiness Questionnaire (PAR-Q) or physician approval as needed based on the pre-screening/PAR-Q responses
Exclusion Criteria
- •Not available for the study duration
- •Unable to communicate by phone
- •Unable to attend exercise class at schedule time (M,W,F, time TBD)
- •Currently enrolled in another exercise program
- •Unable to communicate in English
Arms & Interventions
Intervention Group - Remote Enhance Fitness
Participants assigned to the intervention group will participated in a 16-week remote exercise intervention. Following a home/space environment and technology needs assessment, participants will attend a one-on-one orientation and practice class with a research assistant. Participants will join a live-streamed, instructor-led group Enhance Fitness exercise session for 1-hour, 3 days/week for 4 months (16-weeks).
Intervention: Remote Enhance Fitness (Behavioral)
Waitlist Control
Participants randomized to the waitlist control group will be offered the opportunity to participate in the Remote Enhance Fitness class after study measures are completed. Cuff weights will be provided along with technical orientation, support, and equipment as needed.
Outcomes
Primary Outcomes
Fatigue
Time Frame: 4 months
The Patient Reported Outcome Measurement System (PROMIS)-29 will be collected which includes 4 items on fatigue. Scale range is 1-5 (Not at all, Very much). Higher scores indicate worse fatigue
Physical Activity (PA) and Sedentary Time Assessment
Time Frame: 4 months
Physical activity and sedentary time will be assessed using the activPAL accelerometer. Participants will wear the device for seven (7) days during each measurement period. Overall PA levels will be assessed via daily step counts and minutes of moderate-to-vigorous physical activity and will be summed across the week. Accelerometer data will also include sedentary time and light physical activity time.
Patient Reported Outcome Measurement System (PROMIS)-Physical Function10a
Time Frame: 4 months
Physical function will be assessed with the PROMIS Physical Function short form. This measure has 10 items and been validated for use in multiple populations including cancer survivors and people with multiple chronic conditions. Scale range is 1-5 (not at all, very much) with higher scores indicating worse physical function.
Sleep disturbance
Time Frame: 4 months
The Patient Reported Outcome Measurement System (PROMIS)-29 will be collected which includes 4 items on sleep disturbance. Scale range is 1-5 (Never, Always). Higher scores indicate worse sleep disturbance.
Secondary Outcomes
- 30 second-sit-to-stand test(4 months)
- Four-stage balance test(4 months)
- Technology Use and Acceptance(4 months)
- Five time sit-to-stand test(4 months)
- Adapted Technology Acceptance Model Scale(4 months)
- Duke Activity Status Index(4 months)
Investigators
Nancy Gell
Associate Professor
University of Vermont